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Single Ascending Dose PK, Oral Bioavailability and Food Effect Study in Healthy Male Volunteers (NLG2111)

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ClinicalTrials.gov Identifier: NCT03852446
Recruitment Status : Completed
First Posted : February 25, 2019
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
NewLink Genetics Corporation

Brief Summary:
This 2-part study will assess the effect of formulation and food on the pharmacokinetics of Indoximod in healthy volunteers. Part 1 is a randomized single ascending dose study of indoximod salt formulation to characterize the PK profile and determine the safety and tolerability of each dose in healthy male volunteers. Part 2 is an open-label, randomized, 3-period, 3-way crossover study. Participants will receive single doses of Indoximod base or salt formulation, in the fasted or fed state.

Condition or disease Intervention/treatment Phase
Healthy Drug: Indoximod HCL (F2) tablets Drug: Indoximod base formulation Other: Placebo Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized Trial to Evaluate the Pharmacokinetics and Safety of Single Ascending Doses of Indoximod HCl (F2) Tablets (Part 1) and to Compare the Oral Bioavailability of Indoximod Cl (F2) Tablets and Indoximod Free Base Capsule Formulations and the Effect of Food (Part 2) in Healthy Male Volunteers
Actual Study Start Date : March 5, 2018
Actual Primary Completion Date : March 5, 2018
Actual Study Completion Date : August 14, 2018

Arm Intervention/treatment
Experimental: Part 1: Single Ascending Dose Drug: Indoximod HCL (F2) tablets
The doses will be ascending per cohort from 600 mg to 2400 mg

Other: Placebo
The matching placebo doses will be ascending per cohort from 1 to 4 tablets

Experimental: Part 2: Bioavailability and Food Effect
  1. Single dose of Indoximod HCL (F2) formulation under fasting conditions
  2. Single dose of Indoximod HCL (F2) formulation under fed conditions
  3. Single dose of Indoximod base formulation under fasting conditions
Drug: Indoximod base formulation
Single oral administration of 1200 mg

Drug: Indoximod HCL (F2) tablets
Single oral administration of 1200 mg




Primary Outcome Measures :
  1. Area Under the Plasma Concentration-Time Curve [ Time Frame: up to 20 Days ]
    Part 2

  2. Pharmacokinetics: Serum concentrations (Cmax/Steady State) [ Time Frame: up to 20 Days ]
    Part 2

  3. Pharmacokinetics: Serum concentrations (Cmax/Steady State) [ Time Frame: up to 4 Days ]
    Part 1


Secondary Outcome Measures :
  1. Percentage of patients with adverse events [ Time Frame: up to 18 Days ]
    Part 1

  2. Percentage of patients with adverse events [ Time Frame: up to 36 Days ]
    Part 2



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Non-smoker for at least 3 months
  • BMI within 18 to 30 kg/m2
  • Able to speak, read, and understand English or Spanish

Exclusion Criteria:

  • Clinically significant cardiac, pulmonary, hepatic or renal disease
  • History of substance abuse or alcohol dependence within past 2 years
  • Inability to fast for a minimum of 14 hours
  • Inability to swallow large capsules/tablets
  • Pending legal charges or is on probation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03852446


Locations
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United States, New Jersey
Frontage Clinical Services, Inc.
Secaucus, New Jersey, United States, 07407
Sponsors and Collaborators
NewLink Genetics Corporation
Investigators
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Study Director: Eugene Kennedy, MD NewLink Genetics Inc

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Responsible Party: NewLink Genetics Corporation
ClinicalTrials.gov Identifier: NCT03852446     History of Changes
Other Study ID Numbers: NLG2111
First Posted: February 25, 2019    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by NewLink Genetics Corporation:
Indoximod

Additional relevant MeSH terms:
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Tryptophan
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs